UK Pips EU To The Post With ‘Project Orbis’ Approval For Tagrisso
EU Early-Use Approval For AstraZeneca’s NSCLC Drug Imminent
The UK drug regulator, the MHRA, has approved its first product under Project Orbis, the US-led international regulatory collaboration scheme it joined four months ago to speed up access to promising cancer medicines.
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Industry has paid millions of pounds under the ongoing UK Voluntary Scheme on Branded Medicines Pricing and Access but there are concerns over poor progress with other commitments that were promised under the scheme for managing branded medicine spend by the National Health Service.
The UK has the potential to fulfill its ambition of being a global superpower in life sciences, but it must not get lost in an echo chamber, says a senior MSD executive.
Competition may be on the horizon but Tagrisso's position as standard of care for EGFR-mutated NSCLC looks solid, not least after a thumbs-up in the EU for the adjuvant treatment of adults with early-stage disease.